BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2964955 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01549
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROGRAM SHOWED FAR FIELD R-WAVE OVERSENSING. THERE WAS A SLIGHT INCREASE IN PACIG THRESHOLD WHICH MAY BE DUE TO THE MEDICATION THE PATIENT IS TAKING. THE PATIENT WILL BE MONITORED. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66777 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)